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FDA NDA · NDA022192

FANAPT

iloperidone

Sponsor: VANDA PHARMS INC

APPLICATION
NDA022192
TYPE
NDA
ORIGINAL APPROVAL
2009-05-06
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

FANAPT · ReferencePrescription
ILOPERIDONE 12MG · TABLET · ORAL
FANAPT · ReferencePrescription
ILOPERIDONE 8MG · TABLET · ORAL
FANAPT · ReferencePrescription
ILOPERIDONE 4MG · TABLET · ORAL
FANAPT · ReferencePrescription
ILOPERIDONE 1MG · TABLET · ORAL
FANAPT · ReferencePrescription
ILOPERIDONE 10MG · TABLET · ORAL
FANAPT · ReferencePrescription
ILOPERIDONE 6MG · TABLET · ORAL
FANAPT · ReferencePrescription
ILOPERIDONE 2MG · TABLET · ORAL

Approval history

2025-01-22Labeling · Supplement 24 · standard — Label ↗AP
2024-04-02Efficacy · Supplement 23 · standard — Label ↗AP
2017-02-23Labeling · Supplement 18 · standard — Label ↗AP
2017-02-23Labeling · Supplement 21 · 901 required — Label ↗AP
2017-01-06Manufacturing (CMC) · Supplement 20 · standardAP
2016-05-26Efficacy · Supplement 15 · standard — Label ↗AP
2016-03-29Manufacturing (CMC) · Supplement 16AP
2016-01-05Labeling · Supplement 17 · 901 required — Letter ↗AP
2015-03-30Manufacturing (CMC) · Supplement 14AP
2014-04-21Labeling · Supplement 13 · standard — Letter ↗AP
2013-07-19Manufacturing (CMC) · Supplement 12AP
2013-07-12Manufacturing (CMC) · Supplement 10AP
2013-05-30Manufacturing (CMC) · Supplement 11AP
2013-01-31Labeling · Supplement 7 · standard — Letter ↗AP
2012-01-27Labeling · Supplement 9 · standard — Label ↗AP
2011-09-07Labeling · Supplement 6 · standard — Letter ↗AP
2011-09-07Labeling · Supplement 5 · standard — Letter ↗AP
2011-03-21Labeling · Supplement 4 · unknown — Letter ↗AP
2010-12-01Labeling · Supplement 2 · 901 required — Label ↗AP
2010-08-24Labeling · Supplement 1 · unknown — Label ↗AP
2009-05-06Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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